Serialisation in Life Science: Time to Harness the Opportunity - PowerPoint PPT Presentation

... bridging your enterprise and your plant Serialisation in Life Science: Time to Harness the Opportunity Europe - Cork Office North America - Massachusetts Office West Coast Office Nore House 36 Mechanic Street 533 Airport Blvd Bessboro Road Unit 109 , Suite 400 Blackrock, Cork Foxboro, MA 02035 Burlingame, CA 94010 Ireland USA USA t: +353 21 4614400 t: +1 774-215-5522 t: +1 650-919-3377 t: 1-877-7784771 f: ++1 (508) 302-5364 e: info@esp.ie w: www.esp-corp.com 1 www.EnterpriseSystemPartners.com

Personal Introduction Eamonn O’Mathuna  Over 26 years as Systems Expert in Big Pharma  Automation Team Leader on Serialisation Project in Genzyme Waterford  Joined ESP in 2012 as Manufacturing Systems Consultant, expert in MES, Automation and Serialisation solutions  Currently Project Manager on Serialisation Rollout in Teva Runcorn, UK www.EnterpriseSystemPartners.com 2

Enterprise System Partners Enterprise System Partners (ESP) is a Global Consultancy Company specialising in; » Manufacturing Execution Systems (MES) » Serialisation, Track & Trace Also ERP & Process Automation but primarily in support of the above www.EnterpriseSystemPartners.com 3

Enterprise System Partners A Global Track Record of Success Pharmaceutical /Biotechnology Medical Device www.EnterpriseSystemPartners.com 4

Agenda  Understanding the Impact of Serialisation on Business  The Business (Case) Drivers for Serialisation  Optimising Your Serialisation Investment  A Proven Serialisation Strategy  Standardisation – An Effective Approach – A Case Study Impact on Business Business Drivers Optimise Investment Strategy Effective Approach www.EnterpriseSystemPartners.com 5

The Impact of Serialisation on Business Serialisation isn’t new… …it has been in industry for decades 2010’s 1990’s 2000’s Pacemaker Impact on Business Business Drivers Optimise Investment Strategy Effective Approach www.EnterpriseSystemPartners.com 6

The Impact of Serialisation on Business Do We Underestimate Serialisation? » Put a serial number on a box. » Read it into a database. » Job Done? Impact on Business Business Drivers Optimise Investment Strategy Effective Approach www.EnterpriseSystemPartners.com 7

Serialization Types End to End (European EFPIA Approach) Tamper Evident Seal Source : EFPIA European Medicines Verification System 11 Mar 2013 Overview Fundamentals Big Picture Business Drivers Execution Closing Comments www.EnterpriseSystemPartners.com 8

Serialization Types Aggregation Pallet Case 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 Unit 1 1 1 1 1 1 1 1 Bundle » Important to remember that once aggregation is complete, it must also be maintained and then broken down as product gets closer to the patient. Overview Fundamentals Big Picture Business Drivers Execution Closing Comments www.EnterpriseSystemPartners.com 9

Serialization Types ePedigree (California) Pedigree is built as product flows through the supply chain Manufacturer Hospital / Pharmacy Distributor Wholesaler Product Flow ESP Serialization Approach Lessons Learned Req's Plans/Progress Next Steps www.EnterpriseSystemPartners.com 1

The Impact of Serialisation on Business Serialisation Impact Enterprise LEVEL 4 Application Manufacturer Distributor/ Hospital / Pharmacy Supplier Distributor (Company Wide) Wholesaler Entire Supply Chain Entire IT Architecture Site Manager LEVEL 3 (Site Level) Serialisation LEVEL 2 Line Manager Impacts the Entire (Line Level) Business LEVEL 1 Device Level Impact on Business Business Drivers Optimise Investment Strategy Effective Approach www.EnterpriseSystemPartners.com 11

The Impact of Serialisation on Business Protect the patient » Counterfeit product is dangerous! More efficient recalls » Minimise patient impact » Minimise financial impact to the company Brand Protection » Protecting your supply chain is critical in protecting your brand » If counterfeiters see your supply chain as being weaker than that of other companies, then they will specifically target your products Avoid Revenue Loss. » Each counterfeit unit is potentially a unit of lost revenue Regulatory compliance. » Meeting regulatory requirements will be mandatory Impact on Business Business Drivers Optimise Investment Strategy Effective Approach www.EnterpriseSystemPartners.com 12

The Impact of Serialisation on Business Main Markets » US Market was driven by CA law. This regulation requires full ePedigree . » Recent Federal (FDA) Drug Quality and Security Act (H.R.3204) if signed will supersede CA law. » Serialisation by Q4 2017 » Aggregation and full traceability by 2023 (FDA to define mechanism) Impact on Business Business Drivers Optimise Investment Strategy Effective Approach www.EnterpriseSystemPartners.com 13

The Impact of Serialisation on Business Main Markets continued » European requirement based on EFPIA guidelines ( European Federation of Pharmaceutical Industries and Associations ) . These require Serialisation with Tamper Evidence and the use of a Randomised set of numbers but not full Track & Trace. Approval expected Q2 2014 » Other markets are tending to go with one or other or a combination of the above. Korea, Turkey, Saudi Arabia Impact on Business Business Drivers Optimise Investment Strategy Effective Approach www.EnterpriseSystemPartners.com 14

The Business (Case) Drivers for Serialisation Impact on Business Business Drivers Optimise Investment Strategy Effective Approach www.EnterpriseSystemPartners.com 15

The Business (Case) Drivers for Serialisation Counterfeit Medicines – Can YOU Tell the Difference? FAKE AUTHENTIC Impact on Business Business Drivers Optimise Investment Strategy Effective Approach www.EnterpriseSystemPartners.com 16

Counterfeits seized in Beijing www.EnterpriseSystemPartners.com 17

Not cGMP www.EnterpriseSystemPartners.com 18

The Business (Case) Drivers for Serialisation Core Business Drivers • Patient Safety • Supply Chain Management SERIALISATION • Business Continuity • Brand Protection Impact on Business Business Drivers Optimise Investment Strategy Effective Approach www.EnterpriseSystemPartners.com 19

Optimising Your Serialisation Investment Impact on Business Business Drivers Optimise Investment Strategy Effective Approach www.EnterpriseSystemPartners.com 20

Optimising Your Serialisation Investment Complexity & Cost of Serialisation ePedigree Aggregation End to End Impact on Business Business Drivers Optimise Investment Strategy Effective Approach www.EnterpriseSystemPartners.com 21

Optimising Your Serialisation Investment Global Considerations » Requires global multifunctional multi-disciplined implementation team (Including Partners) » Anticipate and risk assess any expected changes in regulatory requirements & timelines » Plan artwork changes early » Readiness of CMOs & distribution partners Impact on Business Business Drivers Optimise Investment Strategy Effective Approach www.EnterpriseSystemPartners.com 22

Optimising Your Serialisation Investment Site Considerations » Agree impact on OEE and other KPIs at both ramp-up and steady state » Plan inventory levels well in advance to allow for line installation downtime » Fail safe design of data capture & management Impact on Business Business Drivers Optimise Investment Strategy Effective Approach www.EnterpriseSystemPartners.com 23

A Proven Serialisation Strategy Impact on Business Business Drivers Optimise Investment Strategy Effective Approach www.EnterpriseSystemPartners.com 24

A Proven Serialisation Strategy It is Vital to Approach Serialisation with a Strategy which: » Is not sensitive to subtle changes in regulations » Allows for phased execution » Avoids unnecessary complexity Impact on Business Business Drivers Optimise Investment Strategy Effective Approach www.EnterpriseSystemPartners.com 25

A Proven Serialisation Strategy Requirements High Level Process Design » Top down approach » Clear understanding of market and business requirements from Pharmacy/Hospital right back to Packaging Line » Develop a top level realistic time line » Clearly understand the business and regulatory constraints » Identify, document and clearly communicate the agreed business process to all stake holders Impact on Business Business Drivers Optimise Investment Strategy Effective Approach www.EnterpriseSystemPartners.com 26

A Proven Serialisation Strategy Requirements Typical Plant Level Requirements » No impact to Pack Line capacities » Maintain Paperless (MES) operation » Minimise manual input of data during batch » Ensure data integrity through out all systems particularly at Line level » Obtain Serial Numbers from Corporate server & manage locally » Print serial numbers on each shelf unit (child), Case label (parent), Pallet label (grandparent) Impact on Business Business Drivers Optimise Investment Strategy Effective Approach www.EnterpriseSystemPartners.com 27